The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 23 September 2024
Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize Zerviate (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. 23 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 September 2024
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024
In an interview with broadcast media, US Health and Human Services Secretary Alex Azar said that his department was looking to augment the measures proposed in the White House budget proposal, to further reduce drug prices. 22 February 2018
The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) has voted in favor of a renewed recommendation for the use FluMist Quadrivalent (influenza vaccine live, intranasal) in the US for the 2018-2019 season. 22 February 2018
The UK’s National Institute for Health and Care Excellence (NICE) has today issued a technology appraisal guidance (TAG) for Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), recommending use of the drug on the National Health Service. 21 February 2018
Apricus Biosciences saw its market value take a nosedive on Friday following news that the company had received a complete response letter (CRL) for the New Drug Application of Vitaros (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction. 19 February 2018
The US Food and Drug Administration on Friday approved immuno-oncology drug Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). 19 February 2018
The Russian Federal Anti-Monopoly Service (FAS) has announced its plans to submit a proposal to the national government to speed up state registration of innovative drugs and to create a centralized mechanism for their purchase in the country, according to an official spokesman of head of FAS Sergey Artemyev, reports The Pharma Letter’s local correspondent. 16 February 2018
Recognizing an “urgent need for new medical treatments” for many neurological disorders, the FDA says it's revising its product review team structure and changing the way it communicates scientific and regulatory guidance. 16 February 2018
It has been nearly two years since the UK voted to leave the European Union. While we find ourselves only a year away from the official exit, significant ambiguity remains, and important negotiations still must take place, notes Paul Brooks, executive director of the Regulatory Affairs Professionals Society (RAPS). 16 February 2018
Nexavar (sorafenib) is by no means Bayer’s newest cancer drug but there is life in the blockbuster yet – as shown by a new recommendation from the National Institute for Health and Care Excellence (NICE). 15 February 2018
Ipsen’s good day has got even better with news that the National Institute for Health and Care Excellence (NICE) has recommended Cometriq (cabozantinib) for reimbursement via the National Health Service (NHS) in England and Wales. 15 February 2018
The once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 has received Breakthrough Therapy designation from the US Food and Drug Administration for the treatment of patients with moderate-to-severe atopic dermatitis (AD). 15 February 2018
The US Food and Drug Administration has approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). 15 February 2018
The US Food and Drug Administration has provided guidance on the regulatory path forward to support the New Drug Application (NDA) for opicapone, an investigational drug for Parkinson's disease, after receiving meeting minutes from the January 2018 meeting with the FDA. 15 February 2018
In a fast-moving COPD field where triple combination therapies are driving much of the momentum, GlaxoSmithKline has sought to widen its patient population in Europe. 14 February 2018
The European Commission (EC) has approved Herzuma (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. 14 February 2018
The US Food and Drug Administration has issued an approving statement relating to President Trump’s budget proposal, noting the inclusion of “about $400 million in additional funding,” which would in part “further promote innovation and competition.” 14 February 2018
NICE has published draft guidance that does not recommend Brineura (cerliponase alfa) and made by US rare disease drug developer BioMarin Pharmaceutical. 14 February 2018
Chris Miller, scientific lead at 3D Communications, provides his perspective on the regulatory challenges facing pharmaceutical companies that are developing opioid products designed to deter abuse in an Expert View piece. 14 February 2018
The safety board of the European Medicines Agency says that doctors should stop initiating treatment with Esmya (ulipristal acetate), pending a safety investigation. 13 February 2018